K152581 is an FDA 510(k) clearance for the LifeGlobal Micro Tips, a Microtools, Assisted Reproduction (pipettes) (Class II — Special Controls, product code MQH), submitted by Life Global Group, LLC (Gilford, US). The FDA issued a Cleared decision on April 11, 2016, 214 days after receiving the submission on September 10, 2015. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6130.
| 510(k) Number | K152581 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 10, 2015 |
| Decision Date | April 11, 2016 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | MQH — Microtools, Assisted Reproduction (pipettes) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.6130 |